NCT04324801

Brief Summary

People suffering from chronic pain exhibit changes in the way the central nervous system processes pain. Some of the changes in the central nervous system are associated with how the brain adapts to the process of different stimuli. There are several physiological mechanisms that regulates how the brain adapts to changes and one of these mechanisms is called homeostatic plasticity (or equilibrium plasticity ). In healthy participants homeostatic plasticity mechanisms have been tested and considered normal, whereas in patients with chronic conditions, such as low back pain, this mechanism was shown to be dysfunctional. However, it is unknown when this difference in the pain system develops. It is possible that homeostatic mechanism becomes impaired over a period of time. Current studies have investigate a cohort of patients and there is a lack of longitudinal designs. In order to investigate the long-term effects of pain on homeostatic plasticity mechanisms it is important to first investigate the reliability of the methods. This study will investigate the reliability of two protocols of homeostatic plasticity induction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

March 25, 2020

Last Update Submit

October 6, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

  • Motor evoked potentials change from baseline

    0 minutes post homeostatic plasticity induction

  • Motor evoked potentials change from baseline

    10 minutes post homeostatic plasticity induction

  • Motor evoked potentials change from baseline

    20 minutes post homeostatic plasticity induction

  • Motor evoked potentials change from baseline

    30 minutes post homeostatic plasticity induction

  • Motor evoked potentials change from baseline

    40 minutes post homeostatic plasticity induction

  • Motor evoked potentials change from baseline

    50 minutes post homeostatic plasticity induction

  • Motor evoked potentials change from baseline

    60 minutes post homeostatic plasticity induction

  • Motor evoked potentials change from baseline

    70 minutes post homeostatic plasticity induction

Study Arms (1)

Single arm

EXPERIMENTAL

This is a within-subject repeated-measures design.

Other: Homeostatic plasticity induction using transcranial direct current stimulation

Interventions

Homeostatic plasticity induction using transcranial direct current stimulationOTHER

Homeostatic plasticity will be induced in the left primary motor cortex using tDCS applied for 7 minutes followed by an interval of 3 minutes and another block of 5 minutes of stimulation

Single arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, aged between 18-60 years, right-handed and can speak and understand English.

You may not qualify if:

  • Lack of ability to cooperate
  • History or present chronic pain or current acute pain
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Present and previous neurological disorders such as epilepsy, Alzheimer's disease, dementia, stroke, migraine and other headache disorders, multiple sclerosis, Parkinson's disease, neuroinfections, brain tumors and head trauma.
  • Present or previous musculoskeletal disorders such as tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc.
  • Present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia.
  • Current use of medications that may affect the trial (e.g. analgesics, anti-inflammatories, anti-depressives)
  • Contraindications to TMS application (history of epilepsy, metal implants in head or jaw, etc.)
  • Failure to pass the tDCS screening questionnaire
  • Failure to pass the "TASS questionnaire"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, 9220, Denmark

Location

Related Publications (5)

  • Thapa T, Graven-Nielsen T, Chipchase LS, Schabrun SM. Disruption of cortical synaptic homeostasis in individuals with chronic low back pain. Clin Neurophysiol. 2018 May;129(5):1090-1096. doi: 10.1016/j.clinph.2018.01.060. Epub 2018 Feb 9.

    PMID: 29472134BACKGROUND

  • Thapa T, Schabrun SM. Test-Retest Reliability of Homeostatic Plasticity in the Human Primary Motor Cortex. Neural Plast. 2018 Jun 10;2018:6207508. doi: 10.1155/2018/6207508. eCollection 2018.

    PMID: 29983706BACKGROUND

  • Karabanov A, Ziemann U, Hamada M, George MS, Quartarone A, Classen J, Massimini M, Rothwell J, Siebner HR. Consensus Paper: Probing Homeostatic Plasticity of Human Cortex With Non-invasive Transcranial Brain Stimulation. Brain Stimul. 2015 May-Jun;8(3):442-54. doi: 10.1016/j.brs.2015.01.404. Epub 2015 Apr 1.

    PMID: 26050599BACKGROUND

  • Fricke K, Seeber AA, Thirugnanasambandam N, Paulus W, Nitsche MA, Rothwell JC. Time course of the induction of homeostatic plasticity generated by repeated transcranial direct current stimulation of the human motor cortex. J Neurophysiol. 2011 Mar;105(3):1141-9. doi: 10.1152/jn.00608.2009. Epub 2010 Dec 22.

    PMID: 21177994BACKGROUND

  • Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.

    PMID: 25797650BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

January 15, 2020

Primary Completion

June 9, 2020

Study Completion

June 9, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)